Condition category
Musculoskeletal Diseases
Date applied
13/07/2016
Date assigned
14/07/2016
Last edited
17/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Shoulder pain is very common, with around 1% of adults in the UK consulting their GP about a new shoulder problem each year. Most new cases of shoulder pain are caused by problems with the group of muscles and tendons that surround the shoulder joint (rotator cuff). The rotator cuff can be damaged through irritation and inflammation (swelling), trapping of the tendons and/or muscle tears. The main symptom is pain, both when still and when moving the shoulder. Shoulder pain can seriously affect a person’s ability to work, sleep soundly and perform daily tasks. Common treatments include advice, rest, painkillers, anti-inflammatories, physiotherapy and steroid injections. Currently, it is unclear how best to improve physiotherapy for shoulder pain, as it is not known physiotherapy techniques work best for shoulder pain, how exactly they should be delivered, and whether patients do better if they get a steroid injection before starting an exercise programme. The aim of this study is to find out investigate the effectiveness of a progressive exercise programme supervised over 16 weeks by a physiotherapist compared to a single education/advice session (best practice advice). The study will also test whether getting a corticosteroid injection in the shoulder joint before starting either regime helps to relieve pain, enabling comfortable exercise and improving function.

Who can participate?
Adults who have new (within the last six months) shoulder pain caused by a rotator cuff problem who are not currently being treated with physiotherapy or being considered for surgery.

What does the study involve?
Participants are randomly allocated to one of four groups. Those in the first group take part in a progressive exercise programme, which involves up to six sessions with a physiotherapist over 16 weeks where the exercises become more intense as they go on. Those in the second group receive a single face-to-face session in which they are given education, reassurance and self-management exercise advice, including advice on pain management and how to change their activity so as not to cause more pain (best practice advice session). Those in the third group take part in the progressive exercise programme with the addition of an injection of a steroid and local anaesthetic (numbing injection) once before the programme starts and again afterwards. Those in the fourth group receive the same best practice advice session as group two, but receive a steroid and local anaesthetic injection before and after this session. Participants in all groups are examined and complete a range of questionnaires at the start of the study and then 8 weeks, 6 months and 12 months later in order to see if there have been any changes to their pain levels and shoulder function.

What are the possible benefits and risks of participating?
For those participating in the trial – all will receive some physiotherapy which aims to restore functional movement and reduce pain – the only difference for participants in the trial is that the amount of physiotherapy given will differ as it is not know the best amount of physiotherapy for people to have with a rotator cuff injury. There are no notable risks involved with participating, as all treatments being tested are routinely offered within the NHS.

Where is the study run from?
Nuffield Orthopaedic Centre (Oxford) and at least eight other NHS-based musculoskeletal centres (UK)

When is the study starting and how long is it expected to run for?
June 2016 to May 2020

Who is funding the study?
NIHR Health Technology Assessment Programme (UK)

Who is the main contact?
1. Professor Sally Hopewell (scientific)
sally.hopewell@ndorms.ox.ac.uk
2. Ms Lucy Cureton (public)
grasp@ndorms.ox.ac.uk

Trial website

grasp.octru.ox.ac.uk

Contact information

Type

Scientific

Primary contact

Prof Sally Hopewell

ORCID ID

Contact details

Botnar Research Centre
Windmill Road
Oxford
OX3 7LD
United Kingdom
+44 1865 223458
sally.hopewell@ndorms.ox.ac.uk

Type

Public

Additional contact

Ms Lucy Cureton

ORCID ID

Contact details

Botnar Research Centre
Windmill Road
Oxford
OX3 7LD
United Kingdom
+44 1865 737432
grasp@ndorms.ox.ac.uk

Additional identifiers

EudraCT number

2016-002991-28

ClinicalTrials.gov number

Protocol/serial number

OCTRU0105

Study information

Scientific title

Clinical and cost effectiveness of progressive exercise compared to best practice advice, with or without corticosteroid injection, for the treatment of rotator cuff disorders: a 2x2 factorial randomised controlled trial

Acronym

GRASP

Study hypothesis

The aim of this study is to investigate:
1. Whether people with a rotator cuff problem do better after a progressive exercise programme supervised over 16 weeks by a physiotherapist or after one best-practice advice session with a physiotherapist
2. Whether getting a corticosteroid injection in the shoulder joint before starting either regime helps to relieve pain, enabling comfortable exercise and improving function

Ethics approval

Not provided at time of registration

Study design

Multi-centre phase 3 2x2 factorial randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Rotator cuff problem

Intervention

Patients are randomised equally using an online randomisation system into either receiving:
1. Best practice advice session delivered by a physiotherapist
2. Best practice advice session delivered by a physiotherapist and a subacromial corticosteroid injection
3. Progressive exercise sessions delivered by a physiotherapist
4. Progressive exercise sessions delivered by a physiotherapist and a subacromial corticosteroid injection

The subacromial corticosteroid injection will be given as per its marketing authorisation and in accordance with its normal indication and therapeutic dosage. The corticosteroid will be given together with local anaesthetic in one injection at the same time, or separately, depending on local treatment protocols at sites. The corticosteroid injected will either be 40 mg methylprednisolone (Depo-Medrone) (www.medicines.org.uk/emc/medicine/3549/SPC/Depo-Medrone+40mg+ml/) or 20-40 mg triamcinolone acetonide (Kenalog) (www.medicines.org.uk/emc/medicine/11366), depending on local treatment protocols for subacromial injection at each site. These are the two routinely injected corticosteroids for shoulder pain; there is no clear evidence that either corticosteroid is more effective than another (31). The local anaesthetic will either be 1% lidocaine (up to 5 ml) or 0.5% bupivacaine hydrochloride (up to 10 ml), again depending on local treatment protocols.

Intervention type

Drug

Phase

Phase III

Drug names

Consented participants will be randomised to intervention groups (1:1:1:1) using the centralised computer randomisation service RRAMP (https://rramp.octru.ox.ac.uk) provided by the Oxford Clinical Trials Research Unit (OCTRU).

Group 1: Progressive exercise programme:
The participants randomised to the progressive exercise programme will receive up to six sessions with a physiotherapist over 16 weeks. This programme consists of 3 phases:
Phase 1 – assessment and advice
Phase 2 – progressive structured resistance training
Phase 3 – patient-specific functional restoration

Group 2: Best practice advice session:
The participants randomised to the best practice advice session will receive a single face-to-face session with a physiotherapist, lasting up to 60 minutes. After a comprehensive shoulder assessment, the participants will be given education, reassurance and self-management exercise advice, including advice on pain management and activity modification. They will also be given a simple set of self-guided exercises that can be progressed and regressed depending on their capability.

Group 3: Progressive exercise programme + Methylprednisolone injection or Triamcinolone acetonide injection
Participants receive an injection of 40 mg methylprednisolone (Depo-Medrone) together with local anaesthetic in one injection at the same time, or separately, depending on local treatment protocols at sites OR
Participants receive an injection of 20-40 mg triamcinolone acetonide (Kenalog) together with local anaesthetic in one injection at the same time, or separately, depending on local treatment protocols at sites.
(The local anaesthetic will either be 1% lidocaine (up to 5 ml) or 0.5% bupivacaine hydrochloride (up to 10 ml), again depending on local treatment protocols.)
This injection will be given once before the progressive exercise intervention is delivered, then the progressive exercise intervention is delivered.
The participants randomised to the progressive exercise programme will receive up to six sessions with a physiotherapist over 16 weeks. This programme consists of 3 phases:
Phase 1 – assessment and advice
Phase 2 – progressive structured resistance training
Phase 3 – patient-specific functional restoration
A second injection can be given after 6 weeks, but will only be administered to those patients who receive good initial benefit from their first injection and who request further pain relief to facilitate their exercises.

Group 4: Best practice advice session + Methylprednisolone injection or Triamcinolone acetonide injection
Participants receive an injection of 40 mg methylprednisolone (Depo-Medrone) together with local anaesthetic in one injection at the same time, or separately, depending on local treatment protocols at sites OR
Participants receive an injection of 20-40 mg triamcinolone acetonide (Kenalog) together with local anaesthetic in one injection at the same time, or separately, depending on local treatment protocols at sites.
(The local anaesthetic will either be 1% lidocaine (up to 5 ml) or 0.5% bupivacaine hydrochloride (up to 10 ml), again depending on local treatment protocols.)
This injection will be given once before the best practice advice session is delivered, then the best practice advice session is delivered.
The participants randomised to the best practice advice session will receive a single face-to-face session with a physiotherapist, lasting up to 60 minutes. After a comprehensive shoulder assessment, the participants will be given education, reassurance and self-management exercise advice, including advice on pain management and activity modification. They will also be given a simple set of self-guided exercises that can be progressed and regressed depending on their capability.
A second injection can be given after 6 weeks, but will only be administered to those patients who receive good initial benefit from their first injection and who request further pain relief to facilitate their exercises.

All participants in every group will be followed-up at baseline, 8 weeks, 6 months and 12 months after randomisation.

Primary outcome measures

Shoulder pain and function is measured using the Shoulder Pain and Disability Index (SPADI) at baseline, 8 weeks, 6 and 12 months.

Secondary outcome measures

1. Pain is measured using the Shoulder Pain and Disability Index (SPADI) 5-item subscale at baseline, 8 weeks, 6 and 12 months
2. Function is measured using the Shoulder Pain and Disability Index (SPADI) 8-item subscale at baseline, 8 weeks, 6 and 12 months
3. Health-related quality life is measured using the EQ-5D-5L at baseline, 8 weeks, 6 and 12 months
4. Psychological factors are measured using the Fear Avoidance Belief Questionnaire – physical activity 5-item subscale and Pain Self-efficacy questionnaire (short form) at baseline, 8 weeks, 6 and 12 months
5. Sleep disturbance is measured using the Insomnia Severity Index at baseline, 8 weeks, 6 and 12 months
6. Global impression of treatment is measured using the Patient-rated Likert scale at 8 weeks, 6 and 12 months
7. Return to desired activities is measured using the Patient-reported return to desired activities including work, social life and sport activities at 8 weeks, 6 and 12 months
8. Exercise adherence is measured using the Patient-reported adherence to exercise at 8 weeks, 6 and 12 months
9. Medication usage is measured using the Patient-reported prescribed and over the counter medications, additional steroid injection at 8 weeks, 6 and 12 months
10. Work disability is measured by recording the number of days of sick leave taken at 8 weeks, 6 and 12 months
11. Healthcare use is measured by collecting NHS usage data at 8 weeks, 6 and 12 months
12. Out-of-pocket expenses are measured using patient related recording of out of pocket expenses at 8 weeks, 6 and 12 months

Overall trial start date

01/06/2016

Overall trial end date

31/05/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men and women aged 18 years and above
2. New episode of shoulder pain (i.e., within the last 6 months) attributable to a rotator cuff disorder (e.g., cuff tendonitis, impingement syndrome, tendinopathy or rotator cuff tear) using the diagnostic criteria set out in the BESS guidelines
3. Not currently receiving physiotherapy
4. Not being considered for surgery

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

704

Participant exclusion criteria

1. Participants with a history of significant shoulder trauma (e.g., dislocation, fracture or full thickness tear requiring surgery)
2. Those with a neurological disease affecting the shoulder
3. Those with other shoulder disorders (e.g., inflammatory arthritis, frozen shoulder, glenohumeral joint or instability) or with red flags consistent with the criteria set out in the BESS guidelines
4. Those who have received corticosteroid injection or physiotherapy for shoulder pain in the last 6 months
5. Those with contra-indications to corticosteroid injection

Recruitment start date

01/01/2017

Recruitment end date

31/12/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nuffield Orthopaedic Centre
Windmill Road
Oxford
OX3 7HF
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Joint Research Office
Block 60
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
United Kingdom

Sponsor type

University/education

Website

www.admin.ox.ac.uk/researchsupport/ctrg/

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/05/2021

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

17/10/2016: The public contact has been changed to Lucy Cureton from Vicki Barber.